Sanbor Medical Xiamen Inc

FDA Filings

This page includes the latest FDA filings for Sanbor Medical Xiamen Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3007583504
FEI Number	3007583504
Name	Sanbor Medical Xiamen, Inc.
Owner & Operator	Sanbor Medical
Contact Address	5050 Tilghman Street Suite 410 Allentown PA 18104 US
Official Correspondent	Wayne Meng x-610-5308500-x
US Agent	Wayne Meng SANBOR MEDICAL 484 6642678 wmeng@pmd-healthcare.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	1776 Lv Ling Road Xiamen Fujian, 361009 CN
Establishment Type	Manufacture Medical Device for Another Party (Contract Manufacturer) Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K124045 \| JDR Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Wright Medical Staple	2019-11-20
PMN K190970 \| HWC Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Taylor Bunion	2019-11-18
PMN K081939 \| GEX Sanbor Medical Xiamen, Inc. [Sanbor Medical]	OmniGuide BeamPath? Fiber Optic HandPiece System	2019-11-14
LXH Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Radial Head	2019-10-29
HWT Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Radial Head	2019-10-24
PMN K003126 \| GEI Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Bipolar Needle	2019-08-16
PMN K160014 \| DXN Sanbor Medical Xiamen, Inc. [Sanbor Medical]	PMD Blood Pressure Monitor	2018-05-07
PMN K141362 \| DQA Sanbor Medical Xiamen, Inc. [Sanbor Medical]	PMD Pulse Oximeter	2018-05-07
FRI Sanbor Medical Xiamen, Inc. [Sanbor Medical]	PMD Weight Scale	2018-05-07
PMN K103575 \| BZG Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Spiro PD Personal Spirometer	2016-02-22
EIF Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Paraband Dental	2010-06-24
PMN K882017 \| BSY Sanbor Medical Xiamen, Inc. [Sanbor Medical]	Suction Easy	2009-05-27

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
201811199473	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	SPIROMETER DIAGNOSTIC	57 CTN
201811199473	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	PMD WEIGHT SCALE	57 CTN
201805152055	Pusan,South Korea -> Boston, Massachusetts	FILTERS AND BLOWERS AND ETC221CTNS 12PLTS 11CTNS	221 CTN